FDA WILL REVIEW TWO ROCHE DIAGNOSTICS HPV TESTS

Roche Diagnostics recently announced that the FDA has accepted for review its applications for two human papillomavirus (HPV) tests.

The Amplicor HPV Test is designed to detect 13 common high-risk HPV genotypes in standard clinical samples, Roche said March 5.

Persistent infection with HPV is the principal cause of cervical cancer and its precursor, cervical intraepithelial neoplasia, the firm noted. High-risk HPV types are detected in 99 percent of cervical cancers, and approximately 70 percent of cervical cancers are due to HPV types 16 and 18.

Citing a study published in the Feb. 28 issue of The Journal of the American Medical Association, Roche said its prototype of the Linear Array HPV genotyping test led researchers to conclude that the overall prevalence of HPV infection was higher than previous estimates, at 26.8 percent.